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Published on December 28, 2007

Author: Felipe

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Legal Embodiment of Co-Existence of GMOs in Austria :  Legal Embodiment of Co-Existence of GMOs in Austria Dr. Michel Haas, Federal Ministry for Health and Women I. EU-Legislation :  I. EU-Legislation 1. Directive 2001/18/EC   –   decentralized but harmonized procedure for approving GMOs except GMOs for food and feed purposes. At present: seeds are covered by this Directive Interdependence with Regulation 1829 /2003 not yet cleared. –   Austrian national safeguard measures are still applicable. I. EU-Legislation :  I. EU-Legislation 2. EG-Directives on seeds and seed varieties   Regulate the quality standards of seeds and criteria for marketing and labelling of GM-Seed varieties. No GM-seed may be marketed without prior approval according to Directive 2001/18/EC and after an environmental risk assessment acc. to Annex II of this Directive has been performed. I. EU-Legislation :  I. EU-Legislation 3. Regulation 1830/2003 on traceability and labelling of GMOs   At first stage of marketing and at subsequent stages the receiving operator must be informed in writing about   –   that the product contains or consists of GMOs –   the Unique Code (according to EU Regulation 65/2004) –   in mixtures of GMOs (for direct use as food or feed or for processing) a list of the unique codes of the GMOs used to constitute the mixtures must be attached –   documentation must be kept for 5 years –   threshold levels for contamination established (except seeds) all GMOs must be labelled as GMOs I. EU-Legislation :  I. EU-Legislation This regulation is a horizontal regulation for all GMOs and products produced from GMOs and covered by Community Legislation (including seeds). I. EU-Legislation :  I. EU-Legislation 4. Legislation on Organic farming   –  no use of GMOs –  no thresholds yet established at EU-level –  In Austria according to a Guideline of the Austrian Codex Commission (Subcommission for Organic Farming) at present thresholds for adventitious contamination of products from organic farming are 0.1% for food and feed. - Austrian Codex-Guideline on GM-free labelling(process orientated control) I. EU-Legislation :  I. EU-Legislation 5. Recommendation 2003/556/EC of the European Commission of 23 July 2003 (Guidelines for Coexistence)   –  non binding recommendation –  shall guarantee freedom of choice –  mainly agro-economical aspects II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures Austria by its constitution is a Federal State. Competences are divided between the Federal Government (Bund) and the nine Austrian provinces (Länder). II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.Federal legislation and national measures 1.1. Austrian Law on Genetic Engineering (Gentechnikgesetz) as amended in October 2004   –   Transposition of Directive 2001/18/EC (deliberate release and putting on the market of GMOs) Competence: Federal Ministry of Health and Women, which is also mainly competent for implemention of EU-Legislation on genetically modified food and organic farming(in cooperation with the Ministry for Agriculture,Forestry,Environment and Watermanagement).For research activities with GMOs at university level the Ministry for Science, Education and Culture is the Competent Authoritiy II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures –   additional regulations on civil liability –  Responsible care: Those who market GMOs have to take specific care for avoiding comingling GMOs with products which by their destination should not contain GMOs –   Thresholds according to EU-Legislation –  Subsidiary threshold 0,1 % (for accidental contamination of products with GMOs for which no binding EU-threshold has been estabished). II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures –  Federal Register   The law entitles the Ministers for Health and Women and for Agriculture, Forestry, Environment and Watermanagement to issue further regulations on the existing Federal Register of approved GMOs in order to include also the locations of deliberate releases of GMOs and the locations of the cultivation of GM-Plants in the Federal Register(this in cooperation with the federal provinces). It is planned to take up only essential dates from the provincial registers into the federal register. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.2. New regulations regarding civil liability (§§ 79k – 79m Gentechnikgesetz)    A Farmer may by court interdict GMO-pollution from a neighbouring GMO-farm the pollution must have caused an economic damage to his agricultural products the GMO farmer must pay compensation for this damage and the costs for necessary environmental sanitation measures burden of proof lies mainly with by GMO-farmer Before a court decision an official mediator has to try to find a solution within 3 months II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.3. National measures based on the safeguard clause of Directive 2001/18/EC and on the Austrian Genetechnology Act    –  Based on the precautionary principle –  bans on Maize BT 176, MON 810 and T 25 (in particular cultivation) II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.3.1. Argumentation: BT 176 a) The transgenic maize line contains the Ampicillin-resistance-gene including its bacterial regulatory sequences. The probability of gene-transfer of a functional bla-construct into bacteria – even though it is considered low – has to be taken into account for the risk assessment, in regard of antibiotic-resistance. b) The environmental risk assessment has been considered as insufficient: The possible unintended effects of the Bt-toxin on non-target-organisms and the possible resistance-development in insects, e.g. the European corn borer, has not been thoroughly assessed. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures MON 810   a) Risk assessment on indirect and long term effects of the Bt-toxin is missing. b) The environmental risk assessment has been considered as insufficient: The possible unintended effects of the Bt-toxin on non-target-organisms and the possible resistance-development in insects, e.g. the European corn borer, has not been thoroughly assessed. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures T 25   a)  The environmental risk assessment has been considered as insufficient because it has not taken into account an integrated point of view of the use of herbicides under realistic conditions. b)  Possible long term effects and ecological aspects have not been scientifically assessed. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures Recent scientific findings concerning the risk-assessment in regard of allergenicity and toxicity and possible adverse effects of BT-Maize for the environment underline the precautionary approach of Austria. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.3.2. State of Play 29 November 2004 – Regulatory Committee 2001/18/EC    –    EC asks for repealing 8 national bans (France, Germany, Greece, Luxembourg and Austria) –    strong majority of Member States against EC-Proposals –    Austria asked for postponement of these decisions to a date after the WTO-Procedure has been terminated and until a new evaluation acc. to Dir. 2001/18/EC takes place (October 2006) –    EC did not react, although no member state was against this proposal –    Letter of Ministers Pröll and Rauch-Kallat to the EC in December 2004, requests withdrawal of EC-Proposals II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.3.3. WTO-Procedure   Opinions of scientific experts are now discussed (controversial opinions) II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.3.4. Resümee: The most efficient means for coexistence with NON-GMO-Farming at present is not to use GMO-Plants as long as their safety to health and environment is not clearly established (and as long coexistence cannot be guaranteed). II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.4. Measures initiated by the Ministry for Agriculture, Forestry, Environment and Watermanagement    Austrian Act on Seeds   –  Regulation on GMO-Seeds (Saatgut-Gentechnikverordnung) –  Absence of GMOs (tolerance level of 0,1 % in enforcement control) for contamination of conventional certified seed II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures –  Regulation on cultivated areas for seedproduction –   In order to avoid unintended gene transfer, closed, geographically delimited areas are provided for the seed production of certain species of crops, which are likely to be effected by contamination. Regular interdisciplinary Working Group for the establishment and implementation of the Austrian Strategy on Coexistence (Experts of Ministries, AGES and the federal provinces) Austrian Charter for freedom from GMOs II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.5. Measures of the nine Federal Provinces (Competence: Agriculture, Protection of Nature)    1.5.1. Legal actions to establish precautionary measures to prevent the unintentional presence of GMOs in other products and to ensure Coexistence of eventual GMO-farming with organic farming and conventional GMO-free farming and to preserve wildlife and plants in protected nature conservation areas. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.5.2. Model is the    –   Carinthian Genetic Engineering Precautionary Law –   Salzburg has already enacted a similar law –   Tirol, Burgenland, Steiermark, Lower Austria and Vienna shall follow –   Upper Austria has similar plans but wants to await prior the Ruling of the European Court on its Law to forbid GMOs in Upper Austria II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.5.3. Main Content Each Cultivation of GMO must be notified to the provincial Authority three months before cultivation is planned.   The cultivation must either be approved or not be interdicted by the Authority (if coexistence is guaranteed or natural protected areas are not endangered) The Authority may impose specific conditions for cultivation II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures Each GMO cultivation must be registered in a provincial GMO-Register.   This Register is accessible to the public   Some Provinces foresee additional regulations concerning liability and compensation for damage II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.5.4. Conformity with EU-Law Carinthia and Salzburg notified their draft precautionary laws to the Commission which in principle accepted the proposed measures. II. Austrian Legislation and national measures :  II. Austrian Legislation and national measures 1.5.5. Charter of”GMO free Regions” The provinces of Upper Austria, Salzburg, Steiermark and Burgenland together with 16 other European Regions have signed this Charter in Florenz on 4 February 2005 in order to elaborate and to implement measures to prevent traditional and organic farming from GMO-Contamination and to define regions or zones within the region as “GMO –free” -in accordance with existing EU-Legislation. Prior Carinthia has already launched a similar inititative together with Slovenia and Friaul). III. Coexistence Measures in Neighbouring Countries :  III. Coexistence Measures in Neighbouring Countries 1. Germany Amendment to the German Law on Genetechnology new comprehensive legislation on coexistence Aims to protect organic and GMO-free farming Strict liability for GMO-farmers in case of contamination of neighbouring GMO-free-farmers and compensation for economical damage III. Coexistence Measures in Neighbouring Countries :  III. Coexistence Measures in Neighbouring Countries Germany: protection of sensitive ecological areas Good Agricultural Practice Federal Register obligation for retailers to avail product information of GMO-seed III. Coexistence Measures in Neighbouring Countries :  III. Coexistence Measures in Neighbouring Countries 2. Italy New Law on coexistence (24/01/05) strict separation between GMO-farming and traditional/organic-farming Regions (Provinces) must elaborate coexistence management programs expert panel at the Ministry of Agriculture to develope technical guidlines (within 4 months) high protection for biodiversity and financial promotion of traditional and organic farming

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